ID EXISTS
POS 4332
Status 5
DJM 1

Clinical Development Medical Director - Breast Cancer

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Clinical Development Medical Director - Breast Cancer (M/F/*)
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Tasks:
  • Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
  • Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
  • Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
  • Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
  • May be the Program Manager of other associates (e.g.., CSE).
  • May act as study medical monitor
  • Supports (Sr.) Global Program Clinical Headin ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
  • Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
  • As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
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Qualifications:
  • Start: 01.05.2021 // Duration: 5 months + // Capacity: 40 h/week
  • MD or equivalent medical degree required
  • Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification
  • Over 4 years of Clinical practice experience (including residency)
  • Experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV
  • Advanced knowledge in the field of Oncology (Breast Cancer)
  • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
Bemerkungen: WANTED: Clinical Development Medical Director - Breast Cancer (M/F/D). Please contact +49 89 18 90 998 600 or jean-luc.schwind@k-recruiting.com Skills: Clinical Development / Study Design, English, Medical Director, Novartis Vorerfahrung (CH), Oncology
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Interesse geweckt?
Auf geht's!
Beginn: 01.05.2021
Laufzeit: 5 months +
Einsatzort: Basel, Switzerland
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